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Home » MRCT Unveils DCT Toolkit for IRBs and Ethics Committees
MRCT Unveils DCT Toolkit for IRBs and Ethics Committees
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July 10, 2023
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With the help of a multistakeholder task force that included the FDA, sponsors, sites, ethics committees and patient advocates, the Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard has published a toolkit that lays out critical ethical considerations for decentralized trials (DCT).
Codeveloped with DCT support company Medable, the toolkit aims to standardize IRB and ethics committee (EC) reviews of DCTs with a general framework, tools and best practices, an ethics roadmap and guidance on the information sponsors and investigators should provide to IRBs for DCTs.
The recommendations in the toolkit include a summary of ethical issues associated with each decentralized approach, as well as a checklist that IRBs/ECs can use in their reviews and sites and sponsors can use to plan trials and communicate more effectively with IRBs/ECs.
The 12 separate guides that make up the toolkit cover such topics as participant use of technology, recruitment, eConsent, direct-to-patient shipping, remote visits and real-time data monitoring.
The key ethical considerations behind DCTs — data privacy, security and quality — are the same as those for traditional trials but they are more prominent in DCTs due to the greater risks at hand, Pamela Tenaerts, Medable’s chief scientific officer, told CenterWatch Weekly. A trial that uses video conferencing, for example, may be more susceptible to privacy breaches because participants may not have a location to do their video calls privately, while shared family computers raise privacy concerns that wouldn’t be encountered in traditional trials.
Access to high-speed internet is another important ethical consideration that comes into play for DCTs, as is the provisioning of digital devices and wearable sensors, added Barbara Bierer, faculty director of the MRCT Center and professor of medicine at Harvard Medical School.
“The provisioning of digital devices and wearable sensors is an important ethical consideration, both in terms of providing equitable access to these devices and ensuring that the devices themselves have all the safety controls in place and that the data journey from patient to device to vendor to sponsor is safe and secure,” Bierer said.
Until now, ethics committees have not had any common guidelines for streamlining reviews of DCTs or hybrid trials, according to Tenaerts, leading to a lack of consensus and delays among IRBs and ECs. This toolkit will improve review efficiency, she said, and make things easier for stakeholders across the board.
“The lack of standardization impacts efficiency for reviewers as well as sites and sponsors,” she said. “Once the ethical issues are universally identified and defined, committees know what to look for from the beginning, and at the same time, sponsors and sites can prepare the appropriate documentation without a lot of back and forth and starts and stops. It improves everyone’s productivity.”
Access the toolkit here: https://bit.ly/444g7BC.
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